Prashant Patel

FAQ About Prashant Patel

• What is Prashant Patel's address?

  Prashant Patel is located at
  Ahmedabad, Ahmedabad, India

• What is Prashant Patel's job title?

  Prashant Patel is a
  Post graduate in Pharmaceutical Analysis [MS (Pharm)] from National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad and Graduate (B. Pharm.) from Gujarat University. A regulatory professional with an experience of more than 2.5 years at Biocon Ltd, Bangalore. Effectively handled Pre-Clinical, Clinical and Registration related activities w.r.t Biologicals (Novel and Biosimilar) and Small Molecule with Approval Authority (RCGM &DCG (I)). Submission of response to Queries/Deficiencies raised by Regulatory Authorities within timeline Updating of all regulatory guidelines and preparation of checklist for ease of dossier compilation as per trend analysis. Well versed with ICH guidelines and Familiar with USFDA and EMEA guidelines for biological/ biosimilar/combination products Specialties: •Regulatory Strategy Planning and implementation •USDMF, ASMF, CEP and ANDA •RCGM : (IBSC Registration, Import, Export, Transfer and Receive of GMO, Activities Involving Research, Production, Preclinical and other Studies applications) •DCG(I): (Dossier preparation for Clinical trial (Phase I-III) and marketing authorization applications as per CTD Modules) for Biologicals and small molecules Registration of overseas product in India, BA/BE, Import/ Manufacturing Test license, Import/export NOC and Post approvals applications •Design of Experiments (statistical analysis) •Strong analytical skills, Self-motivated, result oriented professional with Team Leadership activity •An effective communicator •Excellent relationship building & interpersonal skills. Pfizer

• What industry does Prashant Patel currently work in?

  Prashant Patel currently works in the
  Pfizer

• What is Prashant Patel's area of expertise?

  Prashant Patel specializes in
  Post graduate in Pharmaceutical Analysis [MS (Pharm)] from National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad and Graduate (B. Pharm.) from Gujarat University. A regulatory professional with an experience of more than 2.5 years at Biocon Ltd, Bangalore. Effectively handled Pre-Clinical, Clinical and Registration related activities w.r.t Biologicals (Novel and Biosimilar) and Small Molecule with Approval Authority (RCGM &DCG (I)). Submission of response to Queries/Deficiencies raised by Regulatory Authorities within timeline Updating of all regulatory guidelines and preparation of checklist for ease of dossier compilation as per trend analysis. Well versed with ICH guidelines and Familiar with USFDA and EMEA guidelines for biological/ biosimilar/combination products Specialties: •Regulatory Strategy Planning and implementation •USDMF, ASMF, CEP and ANDA •RCGM : (IBSC Registration, Import, Export, Transfer and Receive of GMO, Activities Involving Research, Production, Preclinical and other Studies applications) •DCG(I): (Dossier preparation for Clinical trial (Phase I-III) and marketing authorization applications as per CTD Modules) for Biologicals and small molecules Registration of overseas product in India, BA/BE, Import/ Manufacturing Test license, Import/export NOC and Post approvals applications •Design of Experiments (statistical analysis) •Strong analytical skills, Self-motivated, result oriented professional with Team Leadership activity •An effective communicator •Excellent relationship building & interpersonal skills.

• Which languages does Prashant Patel speak? 

  Prashant Patel speaks the following languages:
  No languages available.

• Which industries has Prashant Patel previously worked in?   

  Prashant Patel has prior experience in the following industries:
  Pfizer , Pfizer , Pfizer , Biocon , Biocon , Us Pharmacopoeia

• What is Prashant Patel’s work experience?  

  Prashant Patel has the following professional experience:
  Pfizer , Pfizer , Pfizer , Pfizer , Biocon , Biocon , Us Pharmacopoeia , Pfizer .

• How can I find Prashant Patel on LinkedIn?  

  You can view Prashant Patel’s
  LinkedIn profile at LinkedIn URL.

• What are Prashant Patel’s work email addresses?  

  Prashant Patel’s work email addresses are
  [email protected] .

• What company does Prashant Patel work for?  

  Prashant Patel works at
  Pfizer